First Double-Blind, Placebo-Controlled Published Study of CYPLEXINOL® Finds Significant Improvement in Pain, Stiffness and Quality of Life in Patients with Osteoarthritis

TOMS RIVER, N.J., April 10, 2013 /PRNewswire/ -- ZyCal Bioceuticals, Inc. today announced results of the first double-blind, placebo-controlled study evaluating the benefits of Cyplexinol® in alleviating symptoms of osteoarthritis. The results were published in the April/May 2013 issue of Integrative Medicine: A Clinician's Journal, (http://www.imjournal.com/open_cyp_ost) a peer-reviewed publication providing practitioners with a practical and comprehensive approach to integrating alternative therapies with conventional medicine. According to the study, participants treated with Cyplexinol® reported a significant decrease in pain and stiffness, and a significant increase in quality of life (QOL) as compared to those treated with placebo.

Cyplexinol® is a naturally-derived, biologically active protein complex consisting of bone morphogenetic proteins (BMPs) which stimulate bone and cartilage growth and fight inflammation. Cyplexinol® is the active ingredient in Ostinol™ which is now available directly to consumers as an oral supplement from ZyCal Bioceuticals as well as through Chiropractors and Naturopathic physicians without a prescription.

"Using BMPs to rebuild cartilage and down-regulate inflammatory pathways is a new and exciting approach to managing the debilitating symptoms of osteoarthritis," said Richard Garian, DC, CCSP, one of the study investigators who also co-authored the paper. "For the first time, using rigorous study methods, we were able to demonstrate significant and measurable improvements in pain relief, functionality and quality of life in patients treated with an oral BMP - complex, Cyplexinol® in as little as one week."

In this randomized, double-blind, placebo-controlled clinical trial, 87 participants diagnosed with moderate-to-severe osteoarthritis joint pain in a weight-bearing joint (the hip or knee) were randomized to receive a daily dose of either 150 mg of Cyplexinol® or placebo for 12 weeks. Investigators measured the three primary endpoints – pain, stiffness and QOL – using the Western Ontario and McMaster University (WOMAC) Osteoarthritis Index 3.1. Change in WOMAC scores from baseline to week 1, week 6 and week 12 were calculated.

Significant improvement (decrease) in pain, stiffness, and QOL was observed on the WOMAC subscales for the treatment group. The change in the group's mean scores reached significance in as early as 1 week, with a decrease in pain of 1.57 points (95% CI, 0.74-2.39; P<.0001

Significant improvement (decrease) in pain by 3.35 points (p<0.0001) at week 12 versus those treated with placebo who reported an increase in pain by 0.35 points (p>0.05)

Significant improvement (decrease) in stiffness by 2.95 points (p<0.0001) at week 12 versus those treated with placebo who reported a slight decrease in stiffness by 0.18 points (p>0.05)

Significant improvement (increase) in QOL by 3.12 points (p<0.0001) at week 12 versus those treated with placebo who reported a decrease in QOL by 0.40 points (p>0.05)

"The ability of bone morphogenetic proteins (BMPs) to stimulate bone and cartilage growth is well-documented in peer-reviewed literature and for decades, orthopedic surgeons have used BMPs intra-operatively to treat patients with bone-healing difficulties," said James Scaffidi, President and CEO of ZyCal Bioceuticals, Inc. "In creating Cyplexinol®, the first oral BMP - complex, we are able to bring the benefits of BMPs to the millions of people suffering from debilitating bone and joint conditions."

About ZyCal Bioceuticals, Inc.ZyCal Bioceuticals, Inc. is an innovative nutrigenomics company focused on developing novel biologically active ingredients and products to promote bone and joint health. The company's proprietary ingredient, Cyplexinol® is the first oral, naturally - derived BMP - complex. Cyplexinol® works by stimulating stem cells to grow bone and cartilage tissue as well as helps in the fight against inflammation. The BMPs found in Cyplexinol® are supported by 40 years of scientific and medical research and have been used intra-operatively by surgeons for 25 years. Cyplexinol® is manufactured in a cGMP certified facility, available for licensing and marketed directly to consumers as Ostinol™. For more information on licensing Cyplexinol® or to order Ostinol™ call 1-888-779-9225 ext.104 or visit www.zycalbio.com.